Sets outs requirements and guidance on the management of noise control in occupational settings and applies to all types of workplaces and to all types...

The objective of this document is to provide additional insight and understanding of the requirements in AS ISO 13485:2017, Medical devices - Quality management systems...

Provides an overview and general requirements for the occupational noise management series of Standards.

This Amendment applies to the Clause 2.1.8.2 and Appendix A.

Identically adopts ISO/TR 24971:2020, which provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to AS ISO...